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IMPORTER ALERT! FDA Invalidation of Registrations for Failure to Renew or Complete the Renewal Process

March 2017

fda not approvedCustoms entries could start to be rejected if the facility registrations were not completed for the renewal period for 2016 biennial registration. In addition, FDA food facility registration was invalidated for failure of confirmation by a US Agent and/or foreign manufacturer. If an entry rejection is received for invalid registration, the importer will need to confirm the status of the registration with the manufacturer.

From the U.S. Customs and Border Protection site: 

"FDA invalidated food facility registrations that failed to renew during the 2016 biennial registration period. In addition, food facility registration were invalidated for failure of confirmation by a US Agent and/or foreign manufacturer (registered by a third party) as required under the FDA Food Safety Modernization Act (FSMA), Section 415 of the Federal Food, Drug, and Cosmetics Act (FD&C Act) [21 U.S.C. § 350D] and in accordance with 21 CFR 1.231(a)(5) and (b)(7)." 

Read the entire announcement here

Share: https://compliance.jas.com/ComplianceBlog/Blog266/IMPORTER-ALERT-FDA-Invalidation-of-Registrations-for-Failure-to-Renew-or-Complete-the-Renewal-Process

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